利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数800
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.044752534754724751054750984750864752030.04
212.064776514774124775320.04
单位质量响应值RSD%判断
39468.6939596.350.23数据可信
供试品溶液-2024010711批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1195421-19542136.92734.9110.3736.9334.9110.37
2198052-19805237.42437.42
3195541-19554136.94936.95
4197365-19736537.29437.29
5152496-15249628.81528.82
6169663-16966332.05932.06
10min1238328-23832845.03443.065.5745.1243.145.58
2235930-23593044.58144.66
3236779-23677944.74144.82
4231034-23103443.65643.74
5206377-20637738.99739.06
6218993-21899341.38141.45
15min1254955-25495548.17646.903.8148.3647.073.83
2253082-25308247.82248.00
3254420-25442048.07548.26
4253093-25309347.82448.00
5231624-23162443.76743.92
6241884-24188445.70645.87
20min1263598-26359849.80948.723.6650.1049.003.67
2262818-26281849.66249.95
3263191-26319149.73250.02
4262330-26233049.57049.86
5239669-23966945.28845.54
6255352-25535248.25148.52
30min1274525-27452551.87451.221.8452.2751.611.87
2273365-27336551.65552.05
3274282-27428251.82852.23
4273202-27320251.62452.02
5261618-26161849.43549.78
6269511-26951150.92651.30
45min1282407-28240753.36352.661.8953.8853.161.92
2281693-28169353.22853.74
3281958-28195853.27853.79
4277459-27745952.42852.94
5268607-26860750.75651.21
6280122-28012252.93253.42
60min1287089-28708954.24853.681.5354.8854.291.55
2286454-28645454.12854.76
3286603-28660354.15654.79
4283656-28365653.59954.23
5275591-27559152.07552.65
6284950-28495053.84454.45
极限1290445-29044554.88254.043.1155.6454.783.11
2289704-28970454.74255.49
3289957-28995754.79055.54
4288830-28883054.57755.32
5267941-26794150.63051.32
6289191-28919154.64555.37
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数800
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.044769374764454759804757264759204762020.11
212.064764134765214764670.02
单位质量响应值RSD%判断
39551.6639508.040.08数据可信
供试品溶液-2024010711批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1195010-19501036.85134.8510.2936.8534.8610.29
2197419-19741937.30637.31
3195066-19506636.86236.86
4197159-19715937.25737.26
5152457-15245728.81028.81
6169540-16954032.03832.04
10min1237666-23766644.91243.615.3544.9943.695.34
2235651-23565144.53144.61
3206076-20607638.94239.02
4231137-23113743.67843.76
5236791-23679144.74744.81
6237437-23743744.86944.94
15min1241824-24182445.69846.823.6945.8847.003.68
2252964-25296447.80347.98
3231710-23171043.78743.95
4252837-25283747.77947.96
5253410-25341047.88748.05
6253977-25397747.99448.17
20min1255155-25515548.21748.673.5448.5048.953.52
2262123-26212349.53449.82
3240038-24003845.36045.63
4262159-26215949.54049.83
5262974-26297449.69549.96
6263003-26300349.70049.98
30min1269041-26904150.84151.171.8751.2351.551.87
2273408-27340851.66652.06
3261156-26115649.35149.72
4273179-27317951.62352.02
5274054-27405451.78852.17
6273728-27372851.72752.11
45min1279798-27979852.87452.611.8353.3853.111.83
2281306-28130653.15953.67
3268651-26865150.76751.24
4277239-27723952.39052.90
5281775-28177553.24753.74
6281719-28171953.23753.74
60min1284392-28439253.74253.651.5154.3654.261.52
2286576-28657654.15554.79
3275513-27551352.06452.65
4283780-28378053.62654.25
5286729-28672954.18454.80
6286324-28632454.10754.73
极限1288942-28894254.60253.993.0555.3454.733.04
2289393-28939354.68755.44
3267946-26794650.63451.34
4289152-28915254.64155.39
5289614-28961454.72955.46
6289268-28926854.66355.40
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数800
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.044760964759984755794756924756714758070.05
212.064767734770664769200.05
单位质量响应值RSD%判断
39518.8539545.610.05数据可信
供试品溶液-2024010811批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1151172-15117228.56529.012.1228.5729.012.12
2147989-14798927.96427.96
3155994-15599429.47729.48
4155602-15560229.40329.40
5155748-15574829.43029.43
6154563-15456329.20629.21
10min1212710-21271040.19441.535.2240.2641.595.21
2213279-21327940.30140.36
3230936-23093643.63843.70
4237647-23764744.90644.97
5212133-21213340.08540.15
6211895-21189540.04040.10
15min1238536-23853645.07445.360.7445.2345.520.76
2239795-23979545.31245.46
3241821-24182145.69445.86
4242648-24264845.85146.02
5238671-23867145.09945.25
6238795-23879545.12345.28
20min1252486-25248647.71047.990.4647.9648.250.47
2252852-25285247.77948.03
3255048-25504848.19448.46
4255179-25517948.21948.49
5254650-25465048.11948.37
6253691-25369147.93748.19
30min1268627-26862750.76051.150.4451.1251.520.45
2269990-26999051.01751.38
3271060-27106051.21951.59
4271683-27168351.33751.71
5271631-27163151.32751.69
6271233-27123351.25251.61
45min1278437-27843752.61353.190.8053.0953.670.80
2279134-27913452.74553.22
3281450-28145053.18353.67
4283388-28338853.54954.04
5283525-28352553.57554.05
6283050-28305053.48553.96
60min1284809-28480953.81754.100.6054.4154.700.59
2284343-28434353.72954.32
3285315-28531553.91354.52
4287715-28771554.36754.97
5288311-28831154.47955.07
6287484-28748454.32354.92
极限1288373-28837354.49154.930.5255.2055.650.52
2289395-28939554.68455.39
3290995-29099554.98655.71
4291752-29175255.12955.86
5292155-29215555.20655.92
6291577-29157755.09655.81
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数800
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.044816644820934818424816484817784818050.04
212.064801354797134799240.07
单位质量响应值RSD%判断
40017.0339794.690.40数据可信
供试品溶液-2024010811批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1139181-13918126.05428.154.5326.0528.154.53
2148709-14870927.83727.84
3150359-15035928.14628.15
4160289-16028930.00530.00
5151219-15121928.30728.31
6152400-15240028.52828.53
10min1207802-20780238.89939.731.7238.9639.801.72
2209691-20969139.25239.31
3218356-21835640.87440.94
4211720-21172039.63239.70
5212195-21219539.72139.78
6213776-21377640.01740.08
15min1236602-23660244.29044.671.0244.4344.821.02
2241073-24107345.12745.28
3237268-23726844.41544.57
4241941-24194145.28945.44
5236130-23613044.20244.35
6238658-23865844.67544.83
20min1249473-24947346.69947.500.9146.9447.750.91
2255609-25560947.84848.10
3253780-25378047.50647.76
4255632-25563247.85248.11
5254594-25459447.65847.91
6253275-25327547.41147.66
30min1267572-26757250.08750.881.1750.4351.241.17
2270579-27057950.65051.01
3269986-26998650.53950.90
4275913-27591351.64952.01
5275105-27510551.49751.85
6271807-27180750.88051.24
45min1277847-27784752.01152.700.7452.4753.170.74
2281850-28185052.76053.23
3280688-28068852.54353.01
4282202-28220252.82653.30
5283661-28366153.09953.57
6282865-28286552.95053.42
60min1284472-28447253.25153.580.5253.8254.160.52
2286394-28639453.61154.20
3284681-28468153.29053.88
4286341-28634153.60154.19
5288300-28830053.96754.56
6287153-28715353.75354.34
极限1286891-28689153.70454.380.7054.4055.090.69
2290471-29047154.37455.08
3290312-29031254.34455.05
4290727-29072754.42255.13
5292573-29257354.76755.47
6292149-29214954.68855.40
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